Assessing the Impact of Lipoprotein (a) Lowering With Pelacarsen (TQJ230) on Major Cardiovascular Events in Patients With CVD

Phase 3

Active, not recruiting

• Conditions: Cardiovascular Disease and Lipoprotein(a)
• Interventions: Drug: TQJ230; Drug: Placebo

• Registration Number: NCT04023552
• Lead Sponsor: Novartis Pharmaceuticals

Brief Summary

This is a pivotal phase 3 study designed to support an indication for the reduction of cardiovascular risk in patients with established CVD and elevated Lp(a)

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-07-16
• Study First Submitted QC: 2019-07-16
• Study First Posted: 2019-07-17
• Study Start: 2019-12-12
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-06
• Last Update Posted: 2025-01-07
• Primary Completion: 2025-05-29
• Study Completion: 2025-05-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 8323

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
TQJ230	TQJ230	TQJ230 80 mg injected monthly administered subcutaneously
Placebo	Placebo	Monthly subcutaneous injections.

Primary Outcome Measures

Name	Time	Method
Time to first occurrence of clinical endpoint committee confirmed expanded major adverse cardiovascular events in patients with elevated Lp(a) ≥ 70 mg/dL	approximately 4 years	Demonstrate the superiority of pelacarsen (TQJ230) compared to placebo in reducing the risk of expanded MACE (cardiovascular death, non-fatal MI, non-fatal stroke and urgent coronary re-vascularization requiring hospitalization) in the overall study population with established CVD and (Lp(a) ≥ 70 mg/dL)
Time to the first occurrence of clinical endpoint committee confirmed expanded major adverse cardiovascular events in a population of patients with elevated Lp(a) ≥ 90 mg/dL.	approximately 4 years	Demonstrate the superiority of pelacarsen (TQJ230) compared to placebo in reducing the risk of expanded MACE (cardiovascular death, non-fatal MI, non-fatal stroke and urgent coronary re-vascularization requiring hospitalization) in the overall study population with established CVD and (Lp(a) ≥ 90 mg/dL)

Secondary Outcome Measures

Name	Time	Method
Time to the first occurrence of the clinical endpoint committee confirmed composite endpoint of coronary heart disease: coronary heart disease death, non-fatal MI, urgent coronary re-vascularization requiring hospitalization	approximately 4 years	Demonstrate the superiority of pelacarsen (TQJ230) compared to placebo in reducing the risk of the composite of coronary heart disease (CHD) outcomes: death due to CHD, nonfatal MI and urgent coronary revascularization requiring hospitalization.
Time to the first occurrence of the clinical endpoint committee confirmed composite endpoint of major adverse cardiovascular events (CV death, non-fatal MI, and non-fatal stroke)	approximately 4 years	Demonstrate the superiority of pelacarsen (TQJ230) compared to placebo in reducing the risk of the MACE composite of CV death, nonfatal MI and non-fatal stroke.
Time to Clinical endpoint Committee confirmed all-cause death	approximately 4 years	Evaluation by clinical endpoint committee the rate of all-cause death
Change in Lp(a) in the log scale from baseline	Baseline, year 1	Demonstrate the superiority of pelacarsen (TQJ230) compared to placebo in lowering the Lp(a) level at 1 year

Trial Locations

Locations (34)

SEC Clinical Research LLC; 🇺🇸 Andalusia, Alabama, United States

University of California San Diego; 🇺🇸 San Diego, California, United States

UCSF; 🇺🇸 San Francisco, California, United States

East Coast Institute for Research; 🇺🇸 Jacksonville, Florida, United States

Emory University; 🇺🇸 Atlanta, Georgia, United States

Rush University Medical Center; 🇺🇸 Chicago, Illinois, United States

Horizon Research Grp; 🇺🇸 Lafayette, Louisiana, United States

Tulane Uni Health Sciences Center; 🇺🇸 New Orleans, Louisiana, United States

Grace Research Llc; 🇺🇸 Shreveport, Louisiana, United States

Genesys Regional Medical Center; 🇺🇸 Grand Blanc, Michigan, United States

Mercy Hospital St Louis; 🇺🇸 Saint Louis, Missouri, United States

Heartland Clinical Research Inc; 🇺🇸 Omaha, Nebraska, United States

Lenox Hill Hospital; 🇺🇸 New York, New York, United States

Rochester Regional Health; 🇺🇸 Rochester, New York, United States

Wake Forest University Baptist Medical Center; 🇺🇸 Winston-Salem, North Carolina, United States

Akron Hospital Summa Health System; 🇺🇸 Akron, Ohio, United States

Cardiovascular Res of Knoxville LLC; 🇺🇸 Powell, Tennessee, United States

UT Southwestern Medical Center; 🇺🇸 Dallas, Texas, United States

Grace Research; 🇺🇸 Marshall, Texas, United States

Alpine Research Association; 🇺🇸 Layton, Utah, United States

The University of Utah; 🇺🇸 Salt Lake City, Utah, United States

Inova Fairfax Hospital; 🇺🇸 Falls Church, Virginia, United States

Univ of Washington Medical Center; 🇺🇸 Seattle, Washington, United States

West Virginia University Hospital; 🇺🇸 Morgantown, West Virginia, United States

Novartis Investigative Site; 🇬🇧 Wrexham, United Kingdom

Mercy Gilbert Medical Center; 🇺🇸 Gilbert, Arizona, United States

Cardiovascular Res Found; 🇺🇸 Beverly Hills, California, United States

Saint Johns Hospital; 🇺🇸 Maplewood, Minnesota, United States

Mercy South; 🇺🇸 Saint Louis, Missouri, United States

Albany Medical College; 🇺🇸 Albany, New York, United States

Strong Memorial Hospital; 🇺🇸 Rochester, New York, United States

Medication Management LLC; 🇺🇸 Greensboro, North Carolina, United States

Accellacare US Inc; 🇺🇸 Raleigh, North Carolina, United States

Allegheny General Hospital; 🇺🇸 Pittsburgh, Pennsylvania, United States